Head and Neck CarcinomaNCT05018208
Remote Monitoring in Cancer Care: A Platform Study
An observational study of Head and Neck Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial summary
This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma
- What is being tested?
- Computer-Assisted Intervention, Patient Monitoring and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 17 Apr 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing standard of care CAR-T cell therapy in the outpatient setting at Mayo Clinic. Patients undergoing standard of care radiation for (1) head and neck, (2) lung, or (3) gastrointestinal malignancies.
Who may be able to join
- ARM 1: Age >= 18 years
- ARM 1: Provide written informed consent
- ARM 1: Patients undergoing commercial CAR-T cell therapy in an outpatient setting
- ARM 2: Age >= 18 years
- ARM 2: Provide written informed consent
- ARM 2: Patients with a plan to undergo radiation therapy for lung, gastrointestinal, or head and neck cancer
Who cannot join
- ARM 1: Non-English speaking
- ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
- ARM 2: Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.
Read the detailed description
PRIMARY OBJECTIVES:
- Develop patient-specific algorithms to predict the trajectory of cytokine release syndrome (CRS) and or neurotoxicity and time to escalation of medical intervention is needed. (Arm 1) II. Establish the validity for the use of mobile technology to assess neurologic symptoms remotely. (Arm 1) III. Compare the time to escalation of potential medical intervention between remote monitoring (RM) and standard care (SC) based on retrospective analysis of clinical trial data. (Arm 1) IV. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 1) V. Define the range of physiologic variables associated with receipt of radiation and chemotherapy. (Arm 2) VI. Correlate PROs and physician rated CTCAE to biologic parameters. (Arm 2) VII. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 2)
OUTLINE:
ARM 1: Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks.
ARM 2: Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 60 to 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device.
- Conditions
- Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma, Malignant Digestive System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Computer-Assisted Intervention, Patient Monitoring, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted InterventionOther
Use smartphone app
Patient MonitoringProcedure or surgery
Also called medical monitoring, monitor
Wear Biofourmis wearable device(s)
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (wearable device[s], smartphone app) | Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks. Receives: Other: Computer-Assisted Intervention; Procedure: Patient Monitoring | |
| Arm 2 (wearable device[s], smartphone app, questionnaires) | Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device. Receives: Other: Computer-Assisted Intervention; Procedure: Patient Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
Measured: Up to 5 weeks
Assessment of neurotoxicity via digital capture of neurological assessment (Arm 1)
Will assess agreement and concordance between assessment of neurotoxicity via digital capture of neurological assessment (ICE) as compared to standard in-person assessment.
Measured: Up to 5 weeks
BF-Mayo Neuro test (Arm 1)
Will assess agreement and concordance between BF-Mayo Neuro test and ICE-based assessment of neurotoxicity.
Measured: Up to 5 weeks
Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)
Will compare to standard in-person ICE based neurotoxicity assessment.
Measured: Up to 5 weeks
Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)
Measured: Up to 1 year
Quantification of false alerts and downstream clinical actions (Arm 2)
Will be used for the establishment of the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters.
Measured: Up to 1 year
Secondary outcomes (4)
Biovital index (Arm 1)
Will assess correlation between Biovital index and BF-Mayo Neuro Test and adverse clinical events. Both continuous variables (physiologic parameters) and categorical variables (events) will be used to generate a mixed effects logistic regression model with repeated measures. The goal is to identify patterns of changes in the continuous data associated with either clinically relevant or significant events.
Measured: Up to 5 weeks
BF-Mayo Neuro Test (Arm 1)
Will assess correlation between Biovital index and BF-Mayo Neuro Test and adverse clinical events. Both continuous variables (physiologic parameters) and categorical variables (events) will be used to generate a mixed effects logistic regression model with repeated measures. The goal is to identify patterns of changes in the continuous data associated with either clinically relevant or significant events.
Measured: Up to 5 weeks
Point-in-time assessment of physiological signals from wearable devices (Arm 1)
Will assess agreement and concordance from wearable vs. standard of care devices. Intraclass correlation coefficients (ICC) and Bland-Altman methods will be used for agreement and concordance analysis of the remote monitor reading compared to the "gold standard" standard of care devices.
Measured: Up to 5 weeks
Point-in-time assessment of physiological signals from standard of care devices (Arm 1)
Will assess agreement and concordance from wearable vs. standard of care devices. ICC and Bland-Altman methods will be used for agreement and concordance analysis of the remote monitor reading compared to the "gold standard" standard of care devices.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Dec 2021
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Paludo, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018208
- Sponsor's protocol ID
- MC211001
- Other IDs
- NCI-2021-07955, 21-002043
- Status last verified
- Oct 2025
- First submitted
- 3 Aug 2021
- Last updated
- 30 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes